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Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252027
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

Condition or disease Intervention/treatment
Critically Ill Patients Other: Sample collection

Detailed Description:

An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.

The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole


Intervention Details:
  • Other: Sample collection
    Plasma and urine sample collection


Primary Outcome Measures :
  1. Exposure to fluconazole (trough levels) [ Time Frame: On the day of sampling ]
    To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment

  2. Exposure to fluconazole (trough levels) [ Time Frame: June 2020 ]
    Determine if the Cmin target levels are attained.


Secondary Outcome Measures :
  1. Variability in fluconazole trough levels [ Time Frame: June 2020 ]
    To determine the intra-and intersubject variability of the fluconazole trough levels

  2. Influencing covariates [ Time Frame: June 2020 ]
    Determine possible covariates that might explain the fluconazole variability


Biospecimen Retention:   Samples Without DNA
Blood and urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients.
Criteria

Inclusion Criteria:

  • > 18 years
  • Treatment with fluconazole
  • Admitted to an ICU ward

Exclusion Criteria:

  • < 18 years
  • DNR 2 or 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252027


Contacts
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Contact: Isabel Spriet, PharmD, PhD +32 16 34 30 80 isabel.spriet@uzleuven.be
Contact: Ruth Van Daele, PharmD +32 16 34 30 80 ruth.vandaele@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Isabel Spriet, PharmD, PhD    +32 16 34 30 80    isabel.spriet@uzleuven.be   
Contact: Ruth Van Daele, PharmD    +32 16 34 30 80    ruth.vandaele@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Isabel Spriet, PharmD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04252027    
Other Study ID Numbers: S62242
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Pharmacokinetics
Fluconazole
Variability
Target attainment
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes